NDC 72650-010 Incellderm Active

Niacinamide, Adenosine

NDC Product Code 72650-010

NDC CODE: 72650-010

Proprietary Name: Incellderm Active What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Niacinamide, Adenosine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.
  • Drug uses not available

NDC Code Structure

  • 72650 - Riman Co., Ltd.

NDC 72650-010-02

Package Description: 1 CONTAINER in 1 CARTON > 50 mL in 1 CONTAINER (72650-010-01)

NDC Product Information

Incellderm Active with NDC 72650-010 is a a human over the counter drug product labeled by Riman Co., Ltd.. The generic name of Incellderm Active is niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Riman Co., Ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Incellderm Active Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NIACINAMIDE .75 g/50mL
  • ADENOSINE .02 g/50mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Riman Co., Ltd.
Labeler Code: 72650
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Incellderm Active Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Active ingredients: Niacinamide 1.5%, Adenosine 0.04%

Inactive Ingredient

Inactive ingredients:Centella Asiatica Leaf Water, Water, Centella Asiatica Leaf Water, Citrus Aurantlfolia (Lime) Fruit Extract, Caprylic/Capric Triglyceride, Macadamia Integrifolia Seed Oil, Butylene Glycol Dicaprylate/Dicaprate, Camellia Japonica Flower Extract, Rosmarinus Officinalis (Rosemary) Extract, Calendula Officinalis Extract, Chamomilla Recutita (Matricaria) Extract, Geranium Maculatum ExtractGlycerin, Butylene Glycol, Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Polyglyceryl-4 Caprate, Propanediol, Heptyl Undecylenate, Polyglyceryl-2 Stearate, Glyceryl Stearate, Stearyl Alcohol, Sodium Polyacryloyldimethyl Taurate, Hydrogenated Polydecene, Trideceth-10, 1,2-Hexanediol, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schizandra Chinensis Fruit Extract, Coptis Chinensis Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Caprylyl glycol, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Carthamus Tinctorius (Safflower) Oleosomes, Hydroxydecyl Ubiquinone, Panthenol, Hydrogenated Lecithin, Glycine Soja(Soybean) Sterols, Sodium Hyaluronate, Ethylhexylglycerin, Carbomer, Tromethamine, Sparassis Crispa Extract, Disodium EDTA, Octyldodecanol, Ceramide NP, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Solanum Lycopersicum (Tomato) Callus Culture Extract, Oryza Sativa (Rice) Callus Culture Extract, Ipomoea Hederacea Callus Culture Extract, Panax Ginseng Callus Culture Extract, Nelumbo Nucifera Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Nicotinoyl Tripeptide-1, rh-Oligopeptide-1, Palmitoyl Pentapeptide-4, Alcohol, Acetyl Hexapeptide-8, Hexapeptide-42, Copper Tripeptide-1, Glycine Soja (Soybean) Germ Extract, Madecassoside, Mineral Water, Salix Alba (Willow) Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Cinnamomum cassia bark Extract, Scutellaria Baicalensis Root Extract, Portulaca Oleracea Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Laminaria Digitata Extract, Undaria Pinnatifida Extract, Snail Secretion Filtrate, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract, Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Palmitoyl Tripeptide-5

Purpose

Purpose: Skin Brightening, Anti-wrinkle

Warnings

Warnings:1. Consult a physician if red spots, swollenness, itchiness, or any other adnormal symptoms or side effects develops on the applied area during or after use or under direct sunlight.2. Do not use on wound, etc.3. Precautions for handling and storagea) Keep out of the reach of childrenb) Avoid direct sunlight

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:Helps to brighten the skin.Helps to improve wrinkles in the skin.

Directions

Directions:Take an appropriate amount and spread it evenly over the skin.Please put the appropriate amount on the skin and wait (daub).

* Please review the disclaimer below.